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临床试验/NCT00612300
NCT00612300已完成早期 1 期

The Lokomat Gait Orthosis Compared to Categorized Gait Training by Physical Therapists in Patients Early Post Stroke

University of Aarhus1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
16
试验地点
1
主要终点
10 meters walking test (gait speed)

研究概览

简要总结

The objective of this study is to investigate the effects of an automatic gait trainer (Lokomat) handled by physical therapists compared with categorized gait training by physical therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are used to evaluate study effects.

Hypotheses: 1) The Lokomat improves stroke patients gait speed, distance and symmetry more than categorized gait training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First time Stroke
  • Middle cerebral artery infarction
  • Less than three month from stroke onset
  • Able to walk with or without a stick at gait speed less than 0.5 m/s
  • Participants are able to cope with the Lokomat

排除标准

  • Co-morbidity which impedes study participations
  • Language deficits which makes it impossible to understand oral or written study instructions
  • More than 190 cm tall and 135 kg in weight
  • No gait function prior stroke
  • Skin sore or eruption on lower extremity or trunk, differences in lower extremity length of more than 2 cm or contracture of lower extremity which impedes gait training in the Lokomat -

结局指标

主要结局

10 meters walking test (gait speed)

时间窗: at inclusion, week 3 and week 6

次要结局

  • Six minutes walking test(Inclusion, wek 3 and week 6)
  • Gait symmetry index(Inclusion, week 3 and week 6)
  • Timed Up And Go(Inclusion, Week 3 and Week 6)

研究者

申办方类型
Other

研究点 (1)

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